PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor

Lung Cancer Clinical Trial

Official title:

PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156515
• Other study ID #: 2021KT111
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Hua Zhu
• Phone: 010-88196495
• Email: zhuhuabch[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to construct a noninvasive approach using 68Ga-THP-APN09 PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 18-75, male and female, with ECOG score of 0 or 1;

2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);

3. The expected survival was more than 26 weeks;

4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;

5. According to RECIST1.1, there was at least one measurable target lesion;

6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;

7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria:

1. The function of liver and kidney was seriously abnormal;

2. Preparation for pregnant, pregnant and lactating women;

3. Inability to lie flat for half an hour;

4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.

Related Conditions & MeSH terms

• Lung Cancer
• Melanoma
• PD-L1
• PET/CT

Intervention

Diagnostic Test:
• 68Ga-THP-APN09
APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan.

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPR	In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.	After 2-4 cycles of immunotherapy (each cycle is 28 days)
Secondary	PFS	progression free survival	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.